Data / Medical devices / United States / Menicon America, Inc.

Menicon America, Inc.: FDA-registered device maker in North Billerica, MA, United States, 7 510(k) clearances

Name: Menicon America, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Menicon America, Inc. is registered with the FDA (registration 3003515967) in North Billerica, MA, United States. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 17, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003515967
Address: 76 Treble Cove Rd., Bldg. #3, North Billerica, MA, United States, 01862
Owner or operator: MENICON CO. LTD. (9001029)
Roles: Repackager or relabeler
First device listed: July 7, 2013
Registered through: 2026
Brand names listed: LacriPure, Menicon Progent Protein Remover, Menicon Unique pH Multi-Purpose Solution, Miru 1day UpSide (1 Day SiHy), Miru 1month Menicon (1Month SiHy), Progent Large Diameter Contact Lens Case for Rigid Gas Permeable Lens

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Soft Lens Products	LPN	2	Repackager or relabeler	accessdata.fda.gov
Case, Contact Lens	LRX	2	Repackager or relabeler	accessdata.fda.gov
Lens, Contact, (Disposable)	MVN	2	Repackager or relabeler	accessdata.fda.gov
Lenses, Soft Contact, Daily Wear	LPL	2	Repackager or relabeler	accessdata.fda.gov
Products, Contact Lens Care, Rigid Gas Permeable	MRC	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 17, 2026	K262495	Miru 1day UpSide (midafilcon A)	LPL	Substantially Equivalent	Menicon Co, Ltd.	accessdata.fda.gov
June 17, 2020	K193399	Miru 1day UpSide (midafilcon A)	LPL	Substantially Equivalent	Menicon Co, Ltd.	accessdata.fda.gov
February 22, 2018	K180004	Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens	LPL	Substantially Equivalent	Menicon Co, Ltd.	accessdata.fda.gov
November 16, 2017	K173136	Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses	MRC	Substantially Equivalent	Menicon Co, Ltd.	accessdata.fda.gov
August 28, 2015	K151768	Menicon Saline Rinse Solution	LPN	Substantially Equivalent	Menicon Co, Ltd.	accessdata.fda.gov
July 3, 2013	K130805	MENICON UNIQUE PH MULTI-PURPOSE SOLUTION	MRC	Substantially Equivalent	Menicon Co, Ltd.	accessdata.fda.gov
April 3, 2013	K130285	PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS	LRX	Substantially Equivalent	The Lagado Corp.	accessdata.fda.gov

Compare with other makers

Updated September 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.